Regulations for follow-on NBCDs

Non‐Biological Complex Drugs/Reports | Posted 13/11/2015 post-comment0 Post your comment

Regulations for follow-on versions of non-biological complex drugs (NBCDs) in Europe and the US were discussed at the International Symposium on the Scientific and Regulatory Advances in Complex Drugs, which took place in Budapest, Hungary on 27–28 October 2014 [1].

05 AA011027

The European Medicines Agency (EMA) has recognized the complications associated with approval of originator NBCDs and has in the past therefore requested extra information to support follow-on NBCDs on a case-by-case basis.

EMA has also issued reflection papers outlining the extra data required for approval of follow-on versions of iron-based nano-colloidal products [2] and intravenous liposomal products [3]. The agency has not, however, formally classified certain product families, e.g. glatiramoids, liposomes or iron carbohydrates, as NBCDs. But, nanomedicines are often mentioned in the context of NBCDs.

EMA tends to refer to biosimilars regulations when considering follow-on NBCDs. However, one major difference is the fact that follow-on NBCDs may receive marketing approval through the decentralized route, unlike biosimilars, which must follow the centralized procedure [4].

The US Food and Drug Administration does not formerly recognize NBCDs, with originators required to follow the new drug application route and follow-on NBCDs using the generics – abbreviated new drug application – route. The agency has, however, issued draft guidance documents for certain NBCDs, e.g. liposomes, different iron carbohydrates (iron sucrose, iron gluconate, ferumoxytol) and cyclosporine ophthalmic emulsions.

Conflict of interest
The authors of the conference report [1] did not provide any conflict of interest statement.

Editor's comment
Readers interested to learn more about NBCDs are invited to visit to view the following manuscript published in GaBI Journal:

The authorization of non-biological complex drugs (NBCDs) follow-on versions: specific regulatory and interchangeability rules ahead?

If you are interested in contributing a research article in a similar area to the GaBI Journal, please send us your submission here.

Related articles
Iron carbohydrate follow-on NBCDs

Glatiramoid follow-on NBCDs

Liposomal follow-on NBCDs

Status and regulatory issues surrounding follow-on NBCDs

1. Crommelin DJ, et al. The similarity question for biologicals and non-biological complex drugs. Eur J Pharm Sci. 2015;76:10-7. 
2. GaBI Online - Generics and Biosimilars Initiative. EMA issues reflection paper for follow-on versions of iron-based nano-colloidal products []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from:
3. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for follow-on NBCDs []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13].
4. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from:

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro PharmaCommunications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Equivalence of complex drug products
Non‐Biological Complex Drugs/Reports Posted 14/04/2017
Determining the bioequivalence of follow-on iron formulations
Review committee V15a16
Non‐Biological Complex Drugs/Reports Posted 04/11/2016
Challenges in the assessment of ophthalmic emulsions
Eyedrop Restatis V13H30
Non‐Biological Complex Drugs/Reports Posted 07/10/2016
Iron carbohydrate follow-on NBCDs
Non‐Biological Complex Drugs/Reports Posted 12/08/2016
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010